MAUDE Adverse Event Report: BIOSENSE WEBSTER INC QDOT MICRO¿ CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION

Catalog Number	D139504
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Ventricular Fibrillation (2130)
Date of Event	09/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The bwi product analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc.Or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).
Event or Problem Description
During isvt procedure with two qdot catheters (d-f/f-j), the patient experienced vf (ventricular fibrillation) episode, decreased blood pressure, low ejection fraction, low contraction activity treated with patient own implanted device, chest compressions, medication, switched to general anesthesia, and impella device implant.The patient was transferred to icu and stable.Initially, it was reported that when pacing with the qdot micro catheter d-f catheter, all the ecg (electrocardiogram) signals were lost on just the carto 3 system.The carto 3 system displayed error 1, no communication with the piu (patient interface unit) was detected.The piu was rebooted, and the issue was resolved.The procedure continued.It was reported that towards the end of an ischemic vt case, after re-inducing patient into tachycardia for testing, the medical team had attempted to pace terminate but the morphology had changed and integrated into vf.They then attempted to pace terminate with anti-tachycardia pacing (atp) from the patient's device, and the patient then degraded into vf.They then administered an "external shock," to the patient, and the patient came out of vf.The patient's blood pressure dropped, and there was very low ef (ejection fraction) and contraction activity in the patient's heart.The patient's original ef at the start of the procedure was 10.Then, they administered chest compressions to the patient, as well as medication.There was no confirmation of any details regarding the type of medication or the dosage administered to the patient.When they had started chest compressions, the patient was switched from monitored anesthesia care (mac), to being intubated with general anesthesia.Once the patient's blood pressure had increased, the physician called in interventional surgery.An impella heart device was implanted into the patient, and the patient was then transferred to icu.The patient is in stable condition, but unable to confirm the specific type of injury to the patient.Two different qdot micro catheters were used for ablation during the procedure, a d-f curve and an f-j curve.There are two reports for this event, for both qdot micro¿ catheters.This report is for the f-j curve.
Additional Manufacturer Narrative
On 23-oct-2025, the product investigation was completed.During isvt procedure with two qdot catheters (d-f/f-j), the patient experienced vf (ventricular fibrillation) episode, decreased blood pressure, low ejection fraction, low contraction activity treated with patient own implanted device, chest compressions, medication, switched to general anesthesia, and impella device implant.The patient was transferred to icu and stable.Device evaluation details: the product was returned to johnson & johnson medtech (j&j) for evaluation.A visual inspection and revision of all features were performed following johnson & johnson medtech procedures.Visual analysis revealed no damage or anomalies on the device.The device features were reviewed.No magnetic, force, irrigation, deflection, temperature or electrical issues were found during the product investigation.A manufacturing record evaluation was performed for the finished device 31552743l number, and no internal actions related to the reported complaint condition were identified.The root cause of the adverse event remains unknown.In addition, no device malfunction was reported, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.The instruction for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation, or tamponade.As part of the johnson & johnson medtech quality process, all devices are manufactured, inspected, and released to approved specifications.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

• Brand Name: QDOT MICRO¿ CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: henry boden ; 31 technology dr; irvine, CA 92618 ; 9497882078
• MDR Report Key: 23302824
• Report Number: 2029046-2025-03445
• Device Sequence Number: 11977841
• Product Code: OAE
• UDI-Device Identifier: 10846835016741
• UDI-Public: (01)10846835016741(11)250129(17)280128(10)31552743L
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P210027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: D139504
• Device Lot Number: 31552743L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2025
• Supplement Date Received by Manufacturer: 10/23/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 7FR DECAN,11P,F,2.4MMLE,282MM,; CARTO 3 SYSTEM; NGEN¿ GENERATOR; SOUNDSTAR ECO GE 10F CATHETER
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Sex: Unknown